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临床试验/NCT07613346
NCT07613346进行中(未招募)不适用

A Concurrent Non-Randomized Controlled Trial on Integrated Traditional Chinese and Western Medicine for Patellar Dislocation Pain

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年6月1日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
80
试验地点
1

研究概览

简要总结

This study is a concurrent non-randomized controlled pilot trial. We plan to recruit 80 patients following patellar dislocation surgery from Peking University Third Hospital in China, with at least 40 participants in each group. The study aims to evaluate the safety and efficacy of acupuncture for the treatment of postoperative pain after patellar dislocation. The treatment regimen (pharmacological therapy or acupuncture) will be determined by the clinician and the patient based on the patient's condition and preference.

Participants will be assigned to two groups according to the treatment they receive in clinical practice: a medication group and an acupuncture group. All participants will enter a follow-up phase lasting up to 3 months.

Assessments include pain intensity (Visual Analog Scale, VAS), the Lysholm Knee Score, the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form, the Tegner Activity Score, a sleep score, and the degree of joint swelling. VAS pain score, sleep score, and joint swelling will be evaluated preoperatively and on postoperative days 3, 4, 7, 14, 30, and at 3 months. The remaining outcomes will be measured at 3 months postoperatively.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • patients with recurrent patellar dislocation, male or female;
  • patients with acute patellar dislocation complicated by a tangential osteochondral fracture requiring surgical treatment;
  • patients who voluntarily participated in the clinical trial, signed the informed consent form, and were able to comply with clinical follow-up;

排除标准

  • participation in other drug or medical device clinical trials within the past 6 months;
  • joint fibrosis, ankylosis, or significant limitation of movement;
  • contraindications to MRI examination;
  • other conditions that, in the physician's judgment, preclude participation in the trial.

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Liu Zhenlong

Associate Chief Physician

Peking University Third Hospital

研究点 (1)

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